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Patient Enrollment Completed for Phase 3 Trial of Pafuramidine, Treatment for African Trypanosomiasis
The FDA also granted fast-track designation for this indication and, because of the favorable pre-clinical safety data for pafuramidine in reproductive and juvenile animals, the FDA allowed pregnant women and adolescents to be enrolled in this Phase III trial. Pregnant women and children/adolescents are known to be especially vulnerable to African sleeping sickness and to the risks of toxicity associated with current treatments.
Carol Olson, M.D., Ph.D., Sr. Vice President and Chief Medical Officer of Immtech, stated "We at Immtech and our collaborators at the Swiss Tropical Institute are excited to have completed the enrollment of this Phase III pivotal trial. Without effective treatment, African sleeping sickness is 100% fatal and has the propensity to develop into epidemics. During recent epidemics of African sleeping sickness in several villages in Angola, Sudan, and the Democratic Republic of Congo (DRC), the prevalence rate reached 20% and the disease was the first or second leading cause of death - ahead of even HIV/AIDS. Bringing a new and effective oral drug to market is critical to the fight against African sleeping sickness."
African sleeping sickness is caused by a protozoan parasitic disease spread by tsetse flies in sub-Saharan Africa. It occurs in 36 countries of sub-Saharan Africa, where approximately 60 million people are at risk.
"The WHO, foundations, scientists, governments and non-government organizations (NGOs) collaborate to address international challenges. Immtech looks forward to working with these entities to create sustainable global health solutions." said Eric L. Sorkin, Chairman and Chief Executive Officer of Immtech.
In a previous news release, Immtech stated that a consortium led by the University of North Carolina at Chapel Hill (UNC-CH), of which Immtech is the commercial partner, received grants from the Bill and Melinda Gates Foundation to develop new drugs for protozoan diseases. If the Phase III trial confirms the initial findings and regulators approve pafuramidine, it would become the first oral drug for African sleeping sickness. The availability of an easily- administered oral therapy could help to expand treatment for first-stage African sleeping sickness, targeting the parasite as it circulates in the blood and before it infects the central nervous system.
Dr. Christian Burri, Deputy Head SCIH of the Swiss Tropical Institute, stated: "The research and development of pafuramidine is an excellent example of how we can work together to achieve practical results with innovation, validation, and application of new drugs when targeting challenging global health problems that affect millions of people."
The Phase III pivotal trial is being conducted in six clinical sites in the DRC, Angola, and Sudan and includes approximately 250 first-stage patients. The objective of this randomized, comparative trial is to assess the efficacy, safety and tolerability of pafuramidine versus pentamidine, the current standard therapy for African sleeping sickness. One-half of the patients in the study receive pafuramidine twice daily (200 mg per day total) for ten consecutive days; the other patients receive once-daily injections of pentamidine for seven days. Immtech is blinded to the study drugs administered to individual patients. However, because pafuramidine is administered orally and pentamidine is administered intramuscularly, the patients and investigators are not blinded to the treatments. Immtech plans to perform a protocol-specified interim analysis, which will be performed when half of the patients have completed the 12-month post-treatment visit. This interim analysis is expected to be completed in mid-year 2007. Patients will be monitored for clearance of the parasite at specified intervals for 24 months after the treatment regimen is completed.
Source: Immtech Pharmaceuticals